BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II LVAS

    MDR report key: 2210542 · Received August 10, 2011

    Report

    Report Number
    2916596-2011-00353
    Event Type
    Injury
    Date Received
    August 10, 2011
    Date of Event
    July 12, 2011
    Report Date
    July 14, 2011
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE EXPLANTED DEVICE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION AND IS CURRENTLY BEING ANALYZED. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE DEVICE ANALYSIS IS COMPLETED.

    Description of Event or Problem · 1

    THE PATIENT WAS IMPLANTED WITH A LEFT VENTRICULAR ASSIST DEVICE (LVAD). THE VAD COORDINATOR REPORTED THAT APPROXIMATELY 1 MONTH POST-IMPLANT OF THE LVAD, THE PATIENT PRESENTED WITH ELEVATED TOTAL BILIRUBIN LEVELS AND DECREASED URINE OUTPUT. THE PUMP POWER LEVELS WERE REPORTEDLY DECREASING AND A 3D CT TAKEN BY THE HOSPITAL WAS REPORTED TO SHOW THAT THE INFLOW CONDUIT WAS POTENTIALLY ALIGNED TOWARD THE LATERAL WALL WHICH THE DOCTOR FELT WAS A "PRO-THROMBOTIC" PLACEMENT. A RAMP ECHO WAS NOT PERFORMED AND THE MANUFACTURER WAS NOT CONSULTED. THE HOSPITAL SUSPECTED THROMBUS IN THE DEVICE AND BASED ON THE HOSPITAL'S CLINICAL JUDGMENT, A DECISION WAS MADE TO REPLACE THE LVAD WITH A DEVICE FROM ANOTHER MANUFACTURER. ACCORDING TO THE INFORMATION RECEIVED BY THE MANUFACTURER, THE HOSPITAL DISASSEMBLED THE EXPLANTED LVAD AND REPORTED THAT THE PUMP WAS "CLEAN."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEARTMATE II LVAS LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORP. 104911 105352

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention